Medical Device Report Writer

3 weeks ago

Fairfield Ohio, United States Element Materials Technology Full time
Overview:
Element has an opportunity for a Medical Device Report Writer to join our growing team on-site in Fairfield, OH. The Medical Device Report Writer is responsible for creating and developing quality reports for detailed test processes and results.

 

Element’s Life Sciences group supports developers and manufacturers in the antimicrobial, food and nutraceutical, medical device, and pharmaceutical and biotechnology industries. We provide personalized testing solutions and regulatory consulting support to validate the safety and efficacy of our clients’ products at every stage of development, production and market release.

Responsibilities:
Produces high quality written test reports that detail test processes and results to meet client expectations, applicable standards, and are appropriate for their intended audience

Organizes material and completes writing assignments according to set standards regarding order, clarity, style, brevity, and terminology

Reviews and selects photographs, drawings, sketches, graphs, forms, diagrams, and charts to be incorporated in publications

Maintains records and files of work and revisions

Edits and standardizes material prepared by other writers or personnel, as needed

Acquires and maintains customer and prospective customer contact information

Skills / Qualifications:
Associate’s degree or equivalent from two year college or technical school plus two (2) to four (4) years of relevant experience and/or training; or equivalent combination of education and experience

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or government regulations

Ability to write reports, business correspondence and procedure manuals

Experience working with Quality Management Systems (i.e. ISO 17025 and ITAR Regulations) 

 

This position requires access to export-controlled commodities, technical data, technology, software, and services. U.S. citizenship, U.S. legal permanent resident status, protected person status under 8 U.S.C. § 1324b(a)(3), or U.S. Government export authorization is required. Any offer of employment is contingent upon the employer obtaining the necessary export authorization, including, if required, an export license from the U.S. Department of Commerce’s Bureau of Industry and Security, the U.S. Department of State’s Office of Defense Trade Controls, or other applicable government agency.

#LI-TK1

Company Overview:
Element is one of the fastest growing testing, inspection and certification businesses in the world. Globally we have more than 9,000 brilliant minds operating from 270 sites across 30 countries. Together we share an ambitious purpose to ‘Make tomorrow safer than today’.

 

When failure in use is not an option, we help customers make certain that their products, materials, processes and services are safe, compliant and fit for purpose. From early R&D, through complex regulatory approvals and into production, our global laboratory network of scientists, engineers, and technologists support customers to achieve assurance over product quality, sustainable outcomes, and market access.

 

While we are proud of our global reach, working at Element feels like being part of a smaller company. We empower you to take charge of your career, and reward excellence and integrity with growth and development.

 

Industries across the world depend on our care, attention to detail and the absolute accuracy of our work. The role we have to play in creating a safer world is much bigger than our organization.

Diversity Statement:
At Element, we always take pride in putting our people first. We are an equal opportunity employer that recognizes diversity and inclusion as fundamental to our Vision of becoming “the world’s most trusted testing partner”.

 

All suitably qualified candidates will receive consideration for employment on the basis of objective work related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws or other characteristics in accordance with the applicable governing laws.

 

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c) 

 

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